NEURESCUE Device as an Adjunct to Cardiac Arrest

Not Applicable

Completed

• Conditions: Cardiac Arrest; Cardiopulmonary Arrest; Cardiovascular Diseases
• Interventions: Device: NEURESCUE device

• Registration Number: NCT05146661
• Lead Sponsor: neurescue

Brief Summary

The NEURESCUE device is the first intelligent balloon catheter for aortic occlusion, an emergency technique that supercharges blood flow to the heart and brain within one minute from deployment.

The catheter-based device is delivered via the femoral artery, temporarily inflating a soft balloon in the descending to redirect blood flow towards the upper body.

The objective of the study is to investigate the safety and performance of the NEURESCUE device as an adjunct to Advanced Life Support (ALS) in adults with cardiac arrest.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-12-07
• Study Start: 2022-08-11
• Primary Completion: 2023-11-29
• Study Completion: 2023-11-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Age ≥18 and ≤79 years
2. Witnessed cardiac arrest
3. CPR initiated within 7 min of presumed arrest
4. Cardiac arrest not responding to standard ALS
5. Total CPR time ≤ 40 min at the time of screening for enrollment

Exclusion Criteria

1. Traumatic cardiac arrest
2. Known pregnancy
3. Known terminal disease
4. Known Do-Not-Resuscitate (DNR) order
5. Subjects whose femoral arterial access site cannot accommodate an 8 Fr introducer sheath
6. Subjects currently on mechanical circulatory support

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	NEURESCUE device	The NEURESCUE device will be used as an adjunct to ALS.

Primary Outcome Measures

Name	Time	Method
Successful balloon inflation within 10 minutes from first vessel puncture	Assessed up to 10 min

Secondary Outcome Measures

Name	Time	Method
Time from first vessel puncture to successful sheath insertion	From first needle stick to successful sheath insertion
Rate of occlusion success	Assessed up to 1 hour
Return of spontaneous circulation (ROSC)	Assessed up to 1 hour	The endpoint is dichotomous (yes/no) for each subject
Change in central blood pressure	At the initiation of balloon inflation compared to two minutes after finalizing balloon inflation
Total ALS time at initiation of the investigational procedure	From initiation of ALS to initiation of the investigational procedure
Total cardiopulmonary resuscitation (CPR) time at the screening for enrollment	From initiation of cardiopulmonary resuscitation (CPR) to screening for enrollment

Trial Locations

Locations (2)

Charité - Universitätsklinikum Berlin; 🇩🇪 Berlin, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany